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Emerging diseases: when Random Clinical Trial success means poor economic value

Houy, N.; Flaig, J.

2026-01-21 public and global health
10.64898/2026.01.19.26344387 medRxiv
Show abstract

Using the example of an unknown emerging disease with simple SIR (susceptible-infectious-recovered) dynamics, we show that an efficacy randomized clinical trial (RCT) for a vaccine can be misleading when it comes to the cost-effectiveness of that vaccine. An RCT is more likely to demonstrate efficacy with a high confidence level if it is carried out during the peak of the outbreak. However, in this scenario, the vaccine also has a higher chance of being approved too late to be cost-effective. A vaccine is more likely to be cost-effective if vaccination is implemented in the early stages of an epidemic, but an RCT is more likely to fail to demonstrate efficacy if it is implemented too early, that is when disease transmission is too low.

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